Report: Medical device manufacturers have denied critical resources to nearly half of surveyed medical repair professionals

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Arizona PIRG Education Fund

The coronavirus (COVID-19) pandemic is putting incredible stress on the U.S. medical system, including the equipment that is essential to diagnose and treat patients, such as ventilators. As that equipment is pressed into round-the-clock use, biomedical repair technicians face increasing pressure to maintain and repair all that equipment. However, in too many cases, manufacturers limit access to the essential tools and information these repair experts need. A new report by the Arizona PIRG Education Fund and U.S. PIRG Education Fund, Hospital Repair Restrictions, details the challenges that medical professionals face as a result of device manufacturers setting up barriers to repair, and outlines steps to help hospitals.

The report includes a survey of 222 medical repair professionals from across the country, as well as dozens of interviews. Among the most troubling findings is how common restricted repair is — with 91.8 percent of respondents reporting that they have been denied access to service information for “critical equipment” such as defibrillators, ventilators, anesthesia machines, and imaging equipment.

Nathan Proctor, PIRG Education Fund’s Right to Repair Campaign Director and one of the authors of the report stated, “Manufacturers typically charge much more for repairs than if the hospitals hire a third party or train their own technicians. More costs aren’t the only price of proprietary repair — delays in getting equipment running put patients at risk.”

Since March 2020, the Arizona PIRG Education Fund and U.S. PIRG Education Fund have called for manufacturers of medical devices, especially ventilators, to cooperate with biomedical technicians and provide the information, parts, and other service information needed to repair critical medical equipment. In April 2020, a number of manufacturers responded to public outcry by releasing additional service information for ventilators.

Of the 153 survey respondents whose departments work with ventilators, 29.2 percent report that they currently (as of June 12, 2020) have ventilators that they cannot use because they lack access to parts and service information.

Manufacturers claim that these restrictions are in place to ensure patient safety. However, the Food and Drug Administration (FDA), in a 2018 study, found that third-party repair carries no additional risk and, just like manufacturers, “provide high quality, safe, and effective servicing of medical devices.”

Proctor added, “To help hospitals help patients, barriers to fixing life-saving medical equipment need to be immediately removed.”